A&B Healthcare Week in Review, July 24, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• On July 24, 2015, the Centers for Medicare & Medicaid Services (CMS) announced the extension of temporary moratoria on the enrollment of new ambulance suppliers and home health agencies, subunits, and branch locations in specific locations within designated metropolitan areas in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey to prevent and combat fraud, waste, and abuse. The notice is effective July 29, 2015. The notice states that, “Based upon our consultation with law enforcement and consideration of the factors and activities described previously, CMS has determined that the temporary enrollment moratoria should be extended for an additional 6 months.” More information may be found here.
• On July 20, 2015, the Food and Drug Administration (FDA) announced the availability of a revised draft guidance for industry on lubiprostone capsules entitled ‘‘Bioequivalence Recommendations for Lubiprostone.’’ The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for lubiprostone capsules. Comments should be submitted by September 18, 2015.
• On July 20, 2015, FDA issued a notice entitled “Prescription Drug User Fee Act; Stakeholder Consultation Meetings on the Prescription Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate”. This notice to request that public stakeholders—including patient and consumer advocacy groups, health care professionals, and scientific and academic experts—notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Prescription Drug User Fee Act (PDUFA). The statutory authority for PDUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the prescription drug program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next PDUFA program. The FD&C Act also requires that FDA hold discussions (at least every month) with patient and consumer advocacy groups during FDA’s negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation. Submit notification of intention to participate in these series of meetings by August 28, 2015. Stakeholder meetings will be held monthly. It is anticipated that they will commence in September or October 2015.
• On July 20, 2015, FDA released an information collection activity entitled “Market Claims in Direct-to-Consumer Prescription Drug Print Ads” for public comment. Comments are due September 18, 2015.
• On June 20, 2015, CMS filed in the Federal Register several information collection activities which are now open for public comment. They are entitled: 1) Skilled Nursing Facility (SNF) Prospective Payment System and Consolidated Billing; 2) Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals; and 3) Medicare Beneficiary and Family-Centered Satisfaction Survey. Comments are due September 21, 2015. More information may be found here.
• On July 21, 2015, FDA announced the availability of grant funds for a cooperative agreement to support the FDA Food Safety Modernization Act (FSMA) implementation efforts by the Illinois Institute of Technology’s (IIT) National Center for Food Safety and Technology (NCFST). The estimated amount of support in fiscal year (FY) 2015 will be for up to $5 million (direct plus indirect costs), with the possibility of 2 additional years of support for up to $7 million each year, subject to the availability of funds. This award will improve public health by continued support of an applied research, education, and outreach program related to the science behind and implementation of preventive controls, and on training and technical assistance. The application due date is August 14, 2015.
• On July 23, 2015, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released an Advisory Opinion (No. 15-09) regarding the use of a “preferred hospital” network as part of Medicare Supplemental Health Insurance (“Medigap”) policies, whereby the requestors would indirectly contract with hospitals for discounts on otherwise-applicable Medicare inpatient deductibles for their policyholders, and, in return, , would provide a premium credit of $100 off the next renewal premium to policyholders who use a network hospital for an inpatient stay. OIG concludes that it would not impose administrative sanctions on the requestors in connection with the proposed arrangement.
• On July 23, 2015, FDA announced the availability of a draft guidance for industry entitled ‘‘Gastroparesis: Clinical Evaluation of Drugs for Treatment.’’ This draft guidance is intended to provide FDA’s current thinking regarding clinical trial design and clinical endpoint assessments to support development of drugs for the treatment of diabetic and idiopathic gastroparesis. Comments are due September 21, 2015.
• On July 23, 2015, FDA announced that its Center for Drug Evaluation and Research (CDER) is establishing a public docket to collect comments related to a proposed Study Data Reviewer’s Guide (SDRG) template. As part of FDA’s ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non-profit consortium addressing computational science issues, a PhUSE working group developed the PhUSE SRDG template. The purpose of this review is to evaluate the template and determine whether FDA will recommend its use either as is, or in a modified form, for regulatory submissions of study data. FDA is seeking public comment on the use of the PhUSE SDRG template for regulatory submissions. Please submit either electronic or written comments by September 21, 2015.
• On July 23, 2015, the Department of Labor announced that it is submitting the Employee Benefits Security Administration (EBSA) sponsored information collection request (ICR) titled, ‘‘Affordable Care Act Internal Claims and Appeals and External Review Procedures for Non-Grandfathered Plans,’’ to the Office of Management and Budget (OMB) for review and approval for continued use, without change. The OMB will consider all written comments that agency receives on or before August 21, 2015.
• On July 24, 2015, CMS released the following information collection activities for public comment: 1) State Agency Sheets for Verifying Exclusions from the Inpatient Prospective Payment System and Supporting Regulations; and 2) Consumer Experience Survey Data Collection. Comments are due August 24, 2015. More information may be found here.
• On July 24, 2015, FDA released a proposed rule entitled “User Fee Program To Provide for Accreditation of Third-Party Auditors/ Certification Bodies To Conduct Food Safety Audits and To Issue Certifications”. ) FDA is issuing this proposed rule to amend the proposed rule, ‘‘Accreditation of Third-Party Auditors/ Certification Bodies to Conduct Food Safety Audits and to Issue Certifications’’ (Accreditation of Third-Party Auditors proposed rule) and to propose to establish a reimbursement (user fee) program to assess fees and require reimbursement for the work performed to establish and administer the system for the Accreditation of Third-Party Auditors under the FDA Food Safety Modernization Act (FSMA). DATES: Submit either electronic or written comments on the proposed rule by October 7, 2015.
• On July 24, 2015, FDA released a notice entitled “Analytical Procedures and Methods Validation for Drugs and Biologics”. FDA is announcing the availability of a guidance for industry entitled "Analytical Procedures and Methods Validation for Drugs and Biologics." This guidance supersedes the draft of the same name that published on February 19, 2014, and replaces the 2000 draft guidance for industry on "Analytical Procedures and Methods Validation" and the 1987 FDA guidance for industry on "Submitting Samples and Analytical Data for Methods Validation." This guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.

Event Notices

• September 29, 2015: FDA has announced a workshop entitled ‘‘Medical Device Patient Labeling’’. The purpose of the public workshop is to discuss issues associated with the development and use of medical device patient labeling including content, testing, use, access, human factors, emerging media formats, and promotion and advertising. The Center for Devices and Radiological Health (CDRH) is seeking input into these topics from patients and advocacy groups, academic and professional organizations, industry, standards organizations, and governmental Agencies. Ideas generated during this workshop will help facilitate development or revision of guidances and/or standards for medical device patient labeling. The workshop will be held at FDA’s White Oak Campus.
• October 5, 2015: On July 24, 2015, FDA released a notice announcing a public meeting entitled ‘‘Risk Evaluation and Mitigation Strategies (REMS): Understanding and Evaluating Their Impact on the Health Care Delivery System and Patient Access’’. The purpose of the public meeting is to engage in constructive dialogue and information sharing among regulators, the scientific community, the pharmaceutical industry, public health agencies, patients, patient advocates, health care system administrators, prescribers, dispensers, hospitals, infusion centers, health informatics experts, third-party payers, distributors, and the general public concerning the impact of REMS on the health care delivery system, including the impact on patients and health care providers. The discussion will focus on strategies for characterizing and evaluating the impact of REMS on the health care delivery system and on patient access to drugs subject to REMS. The primary focus of this meeting will be on REMS with Elements To Assure Safe Use (ETASU); however, the meeting will also include discussion of issues that may apply to all REMS. The input from this meeting and the public docket comments will be used to inform ongoing Agency initiatives related to optimizing REMS design, implementation, and assessment. The meeting will take place at 8:00 AM at FDA’s White Oak campus.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On July 22, 2015, the Senate Special Aging Committee convened a hearing entitled “The Doctor’s Not In: Combating Medicare Provider Enrollment Fraud”. Witnesses for the hearing included Shantanu Agrawal, M.D., Deputy Administrator and Director, Center for Program Integrity (CPI), Centers for Medicare and Medicaid Services (CMS); Seto J. Bagdoyan, Director, Audit Services, Forensic and Investigative Service, United States Government Accountability Office (GAO); and Katherine Leff, R.N.; Director, Special Investigations, CareSource Management Group. During the hearing Bagdoyan discussed the results of a GAO report entitled “Medicare Program: Additional Actions Needed to Improve Eligibility Verification of Providers and Suppliers”. To produce the report, GAO examined the implementation of four enrollment screening procedures that CMS uses to prevent and detect ineligible or potentially fraudulent providers and suppliers from enrolling into its Provider Enrollment, Chain and Ownership System (PECOS). Bagdoyan reported that two of CMS's procedures appear to be working to screen for providers and suppliers listed as deceased or excluded from participating in federal programs or health care–related programs. However, GAO identified the following weaknesses in the other two procedures: CMS's verification of provider practice location and physician licensure status. More information on the hearing may be found here.
• On July 23, 2015, the Senate Health, Education, Labor and Pensions (HELP) Committee convened a hearing entitled “Achieving the Promise of Health Information Technology: Information Blocking and Potential Solutions”. Witnesses for the hearing included David C. Kendrick, MD, MPH, Chair, Department Of Medical Informatics, University Of Oklahoma, and CEO, MyHealth Access Network; Michael J. Mirro, MD, FACC, FAHA, FACP, Past Chair, Medical Informatics Committee, American College Of Cardiology, Chief Academic / Research Officer, Parkview Mirro Center for Research and Innovation; David C. Kibbe, MD MBA, President And CEO, DirectTrust Senior Advisor, American Academy of Family Physicians; and Paul M. Black, MBA, President, Chief Executive Officer And Director, Allscripts. More information on the hearing may be found here.
• The Senate Finance Committee on Tuesday approved in a 23-3 vote a $95 billion tax extenders package that would retroactively renew 52 expired provisions through the end of 2016. More information may be found here.

House of Representatives

• On July 22, 2015, the House Ways and Means Health Subcommittee convened a hearing to discuss issues involving hospital payment, rural health, and beneficiary access to care. The sole witness for the hearing was Mark Miller, Staff Director of the Medicare Payment Advisory Commission (MedPAC). During the hearing Subcommittee Chairman Kevin Brady (R-TX) expressed interest in exploring site-neutral payment reforms, noting that MedPAC has found that for some cases, Medicare pays as much as $4,000 more per case simply because there is a discrepancy regarding a patient’s inpatient or outpatient status. He added that because the inpatient and outpatient payment systems are so different, it is difficult to get an accurate assessment of what is driving this trend. “Clearly,” he said, “this is an area ripe for reform”. Brady also cited MedPAC testimony regarding indirect medical education (IME) and disproportionate share hospital (DSH) payments—two 'add-on' payments that certain hospitals receive to help offset the cost of teaching medical students or treating a larger-volume of uninsured or underinsured patients. “I believe both of these programs are critical and need to be designed to deliver the most targeted payments possible,” Brady stated, adding that, “As arbitrary add-on payments, they are not achieving their mission.” More information on the hearing may be found here.
• On Wednesday July 22nd, the full House Veterans Affairs Committee convened a hearing on Department of Veterans Affairs plans to address potential hospital shutdowns if pending budget shortfalls are not resolved. The sole witness was Robert McDonald, Secretary of VA. More information on the hearing may be found here.
• The House Energy & Commerce Committee was scheduled to a hearing entitled "An Overdue Checkup: Examining the ACA's [Affordable Care Act] State Insurance Marketplaces” today, Friday July 24th. However, it was postponed due to a scheduling change in the House of Representatives. Additional information will be made available here.

III. REPORTS, STUDIES, & ANALYSES

• On July 21, 2015, the National Academy for State Health Policy published a brief entitled “State Enrollment Experience: Implementing Health Coverage Eligibility and Enrollment Systems Under the ACA”. Drawing on key informant interviews and ongoing engagement with states between 2013 and 2015, this brief examines states’ early experiences implementing ACA’s eligibility and enrollment requirements; highlights promising practices and lessons learned; provides some context on the state experience; and concludes with possible areas of focus for future enrollment and implementation efforts. With the recent Supreme Court decision in King v. Burwell, there is new momentum for state and federal agencies to learn from early experiences with ACA implementation to further improve enrollment systems in future years.
• On July 22, 2015, CMS released the 2015 Annual Report of the Boards of Trustees of the Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds. According to the report, Medicare’s hospital insurance (Part A) trust fund will run out of money in 2030, the same date as was projected last year. “Growth in per-Medicare enrollee costs continues to be historically low even as the economy continues to rebound. While this is good news, we cannot be complacent as the number of Medicare beneficiaries continues to grow,” said Andy Slavitt, Acting Administrator of CMS of the report. “That’s why we must continue to transform our health care system into one that delivers better care and spends our dollars in a smarter way for beneficiaries so Medicare can continue to meet the needs of our beneficiaries for the next 50 years and beyond."
• On July 23, 2015, a study entitled “Chemotherapy Use, Performance Status, and Quality of Life at the End of Life” was published in the Journal of the American Medical Association (JAMA). Although many patients with end-stage cancer are offered chemotherapy to improve quality of life (QOL), the association between chemotherapy and QOL amid progressive metastatic disease has not been well-studied. American Society for Clinical Oncology guidelines recommend palliative chemotherapy only for solid tumor patients with good performance status. This study sought to evaluate the association between chemotherapy use and QOL near death (QOD) as a function of patients’ performance status. The results showed that although palliative chemotherapy is used to improve QOL for patients with end-stage cancer, its use did not improve QOD for patients with moderate or poor performance status and worsened QOD for patients with good performance status. The QOD in patients with end-stage cancer is not improved, and can be harmed, by chemotherapy use near death, even in patients with good performance status.

IV. OTHER HEALTH POLICY NEWS

• On July 20, 2015, the National Committee for Quality Assurance (NCQA) announced the availability of a new mobile application which lets users search for NCQA-Accredited health plans or NCQA-Recognized clinicians and physician practice sites. “Our evaluation programs are designed to improve the delivery of health care, and with this app everyone can easily access information to help them make an informed decision about their care,” said NCQA Chief Information Officer, Rick Moore. “We are excited to provide this new, easier-to-access format for consumers.”